concept Entero VU Generic Name: barium sulfate Dosage Form: oral suspension Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. NDC 32909-145-06 Entero VU 24% BARIUM SULFATE SUSPENSION (24% w/v, 20% w/w) Entero VU Description Entero VU 24% Barium Sulfate Suspension (24% w/v, 20% w/w) is a barium sulfate suspension for oral administration. Each 100 mL contains 24 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO 4 . Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents. Inactive Ingredients: citric acid, magnesium aluminum silicate, methylcellulose, natural gums, natural and artificial blueberry flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone, sodium benzoate, sodium citrate, and sorbitol. Slideshow Drug Treatments for Rheumatoid Arthritis - What Are Your Options? Entero VU - Clinical Pharmacology Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated unchanged from the body. Indications and Usage for Entero VU For radiography of the gastrointestinal tract. Contraindications This product should not be used in patients with known gastric or intestinal perforation or hypersensitivity to barium sulfate products. Warnings Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur. Precautions General Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease. Ingestion of this product is not recommended in patients with a history of food aspiration. If barium studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. If this product is aspirated into the larynx, further administration should be immediately discontinued. After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose, following completion of the examination may also be required. These mild laxatives are recommended on a routine basis and in patients with a history of constipation unless contraindicated. Use with caution in patients with complete or nearly complete obstruction of the GI tract. Information for Patients Before administration of this product patients should be instructed to: Inform their physician if they are pregnant. Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see PRECAUTIONS-General ). Inform their physician about any other medications they are currently taking. Drug Interactions The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered. Usage in Pregnancy Radiation is known to cause harm to the unborn fetus exposed in utero . Therefore, radiographic procedures should only be used when, in the judgement of the physician, its use is deemed essential to the welfare of the pregnant patient. Nursing Mothers Barium sulfate products may be used during lactation. Adverse Reactions Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. It is of the utmost importance to be completely prepared to treat any such occurrence. ALLERGIC REACTIONS Due to the increased likelihood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure utilizing these products. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 250,000). Such reactions will generally respond to an antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis progressing to unconsciousness. Treatment should be initiated immediately with 0.3 to 0.5 mL of 1:1000 epinephrine subcutaneously. If bronchospasm predominates, 0.25 to 0.50 grams of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reactions for a few hours. The administration of these agents should not be regarded as emergency measures for the treatment of allergic reactions. Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature and are best treated by having the patient lie flat for an additional 10 to 30 minutes under observation. Overdosage On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care. Dosage and Adinistration Shake well prior to use. Pour in a glass and have the patient drink 600 mL within 15 minutes. The first radio-graph (in pronation) should be taken 15 to 20 minutes after the patient started drinking followed by a radiograph every 20 minutes until terminal ileum is visualized radio-graphically. Discard any unused portion. STORAGE USP Controlled Room Temperature, 20 to 25 C (68 to 77 F). Protect from freezing. How is Entero VU Supplied Entero VU 24% is supplied in the following quantity: 600 mL jug, Cat. No. L145, NDC 32909-145-06. Rx Only (USA) Manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc. a subsidiary of Bracco Diagnostics Inc. Monroe Township, NJ 08831 Tel: 1-516-333-8230 1-800 544-4624 rev. 05/14 TX1219-2 2006 E-Z-EM, Inc. Entero VU 24% - 600 ml Barium Sulfate Suspension NDC: 32909-145-06 Entero VU 24% barium sulfate suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:32909-145 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (BARIUM SULFATE) BARIUM SULFATE 240 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACACIA ANHYDROUS CITRIC ACID CARRAGEENAN SODIUM DIMETHICONE 350 DIMETHICONE 1000 MAGNESIUM ALUMINUM SILICATE METHYLCELLULOSE (400 MPA.S) POLYSORBATE 80 POTASSIUM CHLORIDE POTASSIUM SORBATE SACCHARIN SODIUM SILICON DIOXIDE SODIUM BENZOATE SORBITOL TRISODIUM CITRATE DIHYDRATE WATER XANTHAN GUM Product Characteristics Color WHITE Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description 1 NDC:32909-145-06 600 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/30/2000 Labeler - E-Z-EM Canada Inc (204211163) Registrant - E-Z-EM, INC. (002041226) Establishment Name Address ID/FEI Operations E-Z-EM Canada Inc 204211163 LABEL(32909-145), ANALYSIS(32909-145), MANUFACTURE(32909-145), PACK(32909-145) Revised: 11/2014 E-Z-EM Canada Inc Next Pregnancy Warnings Print this page Add to My Med List More about Entero VU (barium sulfate) Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: non-iodinated contrast media Consumer resources Entero VU oral and rectal Entero VU Entero VU (Advanced Reading) Professional resources Other brands: Volumen , Tomocat , Readi-Cat , CheeTah , ... +29 more Other Formulations Entero-H oral and rectal Related treatment guides Computed Tomography} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Non-iodinated contrast media Related Drugs non-iodinated contrast media barium sulfate , Volumen , Tomocat , Readi-Cat , Readi-Cat 2 , Esobar Computed Tomography barium sulfate , iodixanol , Visipaque , Volumen , iopromide , Tomocat , Readi-Cat , Esobar , Ultravist , Liquid E-Z Paque , CheeTah , Readi-Cat 2 , Anatrast , Prepcat , Sitzmarks , E-Z-Paque , Entrobar , Intropaste , ioflupane I 123 , More... 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